Staff Engineer, Quality

Stryker; Waltham (MA); On-site; USD 107,000 - 179,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts is seeking a Staff Quality Engineer to support manufacturing operations, supplier quality, and process performance for existing and new products.

As the site’s primary Quality Engineer, you will establish quality metrics, drive process improvements, support manufacturing readiness activities, and ensure products and processes meet regulatory requirements and customer expectations.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• 4+ years of experience in Quality Engineering/Quality Assurance supporting manufacturing operations in a regulated environment.
• Experience in a regulated manufacturing environment.

Responsibilities

• Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.
• Identify and implement process improvements that enhance product quality, manufacturing efficiency, inspection effectiveness, and compliance.
• Lead investigations of internal and supplier nonconformances, ensuring timely resolution and closure.
• Own CAPAs, using root cause analysis to identify issues and implement sustainable solutions.
• Review and disposition nonconforming product through MRB activities and containment actions.
• Partner with operations and cross-functional teams to resolve quality issues and maintain process compliance.
• Evaluate manufacturing and quality performance metrics, identify trends, and drive continuous improvement initiatives.
• Support manufacturing complaints, product field actions, and quality-related investigations.
• Review and approve change management activities, challenge effectiveness, and verify implementation of quality controls.
• Support process validation, equipment qualification, measurement system analysis, audits, and supplier quality performance activities.

Skills

Quality Engineering

Regulated manufacturing

CAPA

Root cause analysis

Gage R&R

Lean Six Sigma

ISO 13485

GMP

Process validation

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Job description

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff Quality Engineer. In this role, you will support manufacturing operations, supplier quality, and process performance across both existing and new products. Working closely with operations, engineering, suppliers, and cross‑functional partners, you will help ensure products and manufacturing processes meet quality standards, regulatory requirements, and customer expectations.

This role offers a unique opportunity to support a newly integrated business preparing for commercial launch. As the site's primary Quality Engineer, you will play a key role in helping to establish quality metrics, drive process improvements, support manufacturing readiness activities, and enhance long‑term quality and operational performance.

What You Will Do

• Support manufacturing readiness, product transfer activities, and the transition from development to sustaining operations.
• Identify and implement process improvements that enhance product quality, manufacturing efficiency, inspection effectiveness, and compliance.
• Lead investigations of internal and supplier nonconformances, ensuring timely resolution and closure.
• Own Corrective and Preventive Actions (CAPAs), using root cause analysis to identify issues and implement sustainable solutions.
• Review and disposition nonconforming product through Material Review Board activities and containment actions.
• Partner with operations and cross‑functional teams to resolve quality issues and maintain process compliance.
• Evaluate manufacturing and quality performance metrics, identify trends, and drive continuous improvement initiatives.
• Support manufacturing complaints, product field actions, and quality‑related investigations.
• Review and approve change management activities, challenge effectiveness, and verify implementation of quality controls.
• Support process validation, equipment qualification, measurement system analysis, audits, and supplier quality performance activities.

Required Qualifications

What You Will Need

• Minimum bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.
• Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related quality‑focused role supporting manufacturing operations within a regulated environment.
• Experience working within a regulated manufacturing environment.

Preferred Qualifications

• Experience in medical device manufacturing.
• Training or certification in Lean, Lean Six Sigma, or continuous improvement methodologies.
• Experience with process capability analysis, statistical sampling plans, and gauge repeatability and reproducibility (Gage R&R) studies.
• Working knowledge of ISO 13485, Good Manufacturing Practices (GMP), CAPA, risk management, audits, and statistical quality methods

US20: $107,200 - $178,600 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.